The PharmaCertify™ Team

Today is 11-11-11 and the superstitious among us are scurrying about getting married or at least buying lottery tickets. Today is also the last binary day, a date in which no digit exceeds one, (as long as you don’t write out the full year) of the century. And we even have a little joke to celebrate the day: There are 10 kinds of people – those who understand binary and those who don’t.

Most importantly though today is Veteran’s Day (or Armistice Day if you like to roll old school). Before you head out to your local parade or other celebration, we give you this week’s PC News Week in Review.

Last week we discussed Senator Grassley’s displeasure with CMS’s delay in releasing  the Sunshine Act guidelines. This week we get news that CMS says it will most likely be spring of 2012 before the rules are issued. Wow. Let’s hope they mean early spring. Silver lining: at least we have a date, however nebulous.

Not to be outdone, Leon Rodriguez, the new head of the Office of Civil Rights, testified before a Senate subcommittee chaired by Al Franken of Minnesota about a long delayed privacy and security regulatory update mandated by the HITECH Act of HIPAA. The new chief would not offer a timeline for when the long overdue rules could be expected. This did not sit well with Sen. Franken, who said that electronic health records offered a great opportunity to improve efficiency in healthcare, but those benefits would not be realized until patients could be assured their records would be kept private. Don’t let it get you down though Mr. Rodriguez. Just repeat the wise counsel of Stuart Smalley; “I’m good enough. I’m smart enough, and doggone it, people like me.”

Where oh where has my disclosure report gone? Or, where should it go as the case may be in West Virginia. A rule change has caused the governor-elect to withdraw the rules enforcing the state’s disclosure law. The hubbub appears to center on a 2010 modification that changed how and to what agency the reports are submitted. Umm…okay. Moving along…In Pennsylvania, a proposed False Claims Act for the state sits in committee waiting approval. (Go ahead and sing it; we know you want to. “I’m just a bill, yes, I’m only a bill, and I’m sitting here on Capitol Hill). Wrapping up state-based news, the Congressional delegation from Minnesota has signed a letter urging the FDA to streamline the approval process for medical devices.

Over in the UK, Richard Alderman, the director of the Serious Fraud Office (SFO), has confirmed there is Bribery Act enforcement activity occurring in the office. The SFO is working directly with corporations, and as such, much of the information regarding the cases will remain private for the time being. Mr. Alderman said the office is investigating complicated cases, and not just going after the low-hanging fruit.

In China, the former chief executive of a government-owned pharmaceutical company found guilty of embezzlement and accepting bribes was handed a suspended death sentence, with a two year reprieve. The former CEO is said to have collected around $8 million through corrupt means. Suddenly, that 15 year sentence handed down for FCPA violations a few weeks ago doesn’t seem quite so bad.

And speaking of the FCPA, the DOJ announced that it would release new guidance on FCPA civil and criminal enforcement provisions. The new guidance will be released some time next year.

Ethics and compliance has gone from “geek” to chic. (We always knew it was chic!) The head of the Society of Corporate Compliance and Ethics (SCCE) said that companies are taking a new view of ethics and compliance programs and are growing their departments. He says he has seen an increase in membership in the SCCE, and compliance jobs are among the fastest growing in the country. As Huey Lewis said so may years ago, “It’s hip to be square.”

That brings us to the end of this week’s review. We’d like to end this week’s review by saying thank you to our veterans. It is your sacrifice that allows us to remain safe here at home, and go happily about our day writing fun little articles summarizing the news of the week in the world of pharmaceutical and medical device compliance. May God bless you all.

Sean Murphy

Being an exhibitor who also had access to all educational sessions and panels at the Twelfth Annual Pharmaceutical and Compliance Congress and Best Practices Forum in Washington DC offered me the opportunity to evaluate the conference from the perspective of a vendor, and as an attendee eager to absorb as much information as possible. As a vendor, I applaud the efforts of the PCF and the conference chairs to encourage attendees to visit the exhibit hall and explore the solutions offered by the various exhibitors. Throughout the conference, the foot traffic around our booth was high, and the compliance professionals we spoke with were genuinely interested in how our services and products could be utilized to support their training requirements. From an attendee perspective, I also appreciate the effort to schedule as many sessions as possible in the main ballroom, without concurrent sessions happening at the same time. The separate tracks, with the need to forgo some sessions in order to attend others, did not begin until the afternoon of Day 2, so everyone could take in ALL of the sessions until that point.

Of course, since I couldn’t attend all of the tracked sessions once they did begin, I welcome readers’ comments and commentaries on any I missed, or even on those I attended.  With that, here are some of the highlights.

Day 1, Wednesday November 2, 2011

The highlights of Day 1 included the annual presentation by Mary Riordan, Senior Counsel for the OIG, who led off with the news that the OIG will be hosting a roundtable discussion in early 2012 for companies currently under a Corporate Integrity Agreement (CIA). The meeting is intended to allow the companies to share best practices for dealing with the compliance-related issues and a summary of the comments and suggestions will be posted on the OIG website following the meeting. Stay tuned for more details to come from the OIG on the roundtable session.

When reviewing the OIG’s 2012 work plan, Ms. Riordan reminded the audience that holding individuals, including board members and managers, accountable will continue to be a focus of the agency. She also emphasized the need for manufacturers to implement an active Risk Evaluation and Mitigation (REMS) program to address potential issues as early on as possible.

In a session titled, “Coordinating Pharma Prosecutions,” Joyce Branda, Director, Commercial Litigation Branch, US Department of Justice, updated the audience the audience on qui tam cases and informed the audience that there are currently in excess of 150 qui tam cases under seal and the primary issue is off-label promotion. As Ms. Branda put it, “For those of you who say off-label promotion keeps you up at night, it should.”

During his presentation, Thomas Abrams, Director, Division of Drug Marketing, Advertising, and Communications at the FDA, addressed the “hot topic” of social media guidance from the FDA. The FDA held a two day public meeting at which comments were accepted and the data was reviewed and considered in preparation of the guidance. Mr. Abrams informed the audience that guidance on social media will be based on the issues, not on the platforms. Stay tuned.

Day 2, Thursday November 4, 2011

Day 2 began with Kendra Martello, Assistant General Counsel for PhRMA, offering an update on the Sunshine Act. The bottom line – if you’re looking for any news on the CMS releasing the details regarding the procedures for submitting data, don’t hold your breath.

The Thursday presentation on the FCPA and the UK Bribery Act was particularly compelling considering the emphasis on anti-bribery prosecution by the DOJ and other regulatory bodies around the world. In case anyone forgot, Nathaniel Edmonds, Assistant Chief, FCPA Unit, US Department of Justice, told the assembled compliance professionals that the prosecution of individuals, including sales directors, is a stated goal of the DOJ. Vivian Robinson, Partner, McGuireWoods and Former General Counsel of the UK Serious Fraud Office, described the UK Bribery Act as the toughest anti-bribery regulation in the world and gave four reasons why:

• The regulation applies to both public and private companies
• It applies to the recipients of bribes as well as the individual offering the bribe
• It has no allowances for facilitation of services
• It creates a single offense – failing to prevent a bribe from taking place

Mr. Robinson pointed out that the UK Bribery Act does allow for a defense if a company can prove it has anti-bribery procedures in place and the Administry of Justice website lists the six principles required to demonstrate those procedures are in place.

Colleen Conry, Partner , Ropes & Gray, presented a thorough review of the well known “Lauren Stevens” case. Stevens, former in-house counsel for GSK was charged and ultimately acquitted of obstruction of justice and making false statements in connection with GSK’s response to a voluntary request from the FDA for information concerning the promotion of Wellbutrin. The key takeaways from the presentation included the importance of being transparent with all material no matter how irrelevant you think they may be and don’t assume the matter is closed if you don’t hear back from the FDA for many months.

In an afternoon session dedicated to the annual compliance administration survey by PricewaterhouseCoopers, Keith Korenchuk, Partner at Arnold & Porter, Erinn Hutchinson, Director at PwC and Victoria Browning, Senior Director, Corporate Compliance at Allergan, revealed some of the results of the survey. The topic of training was at the top of most respondents’ concerns as 74% of those surveyed said that education and training is where they spend most of their budget and time. The survey also showed the top five compliance areas of concern as:

1. Sales and marketing
2. Use of third parties
3. Anti-bribery/FCPA
4. Aggregate Spend
5. Expansion to less established markets

I was happy to see the organizers and chairs of the conference created sessions dedicated to compliance for the medical device space. During a session titled, “Compliance Lessons Learned from Medical Device,” the challenges unique to the industry were reviewed by a panel led by Arjun Rajaratnam, Chief Compliance Officer at Smith & Nephew and Sujata Dayal, Corporate Vice President and CCO at Biomet. Gray areas like the questions surrounding a rep’s interaction with a surgeon using a device off-label in the operating room were debated and all agreed that the industry presents challenges very different than those in pharma, and professionals on the med device side need to be alert for the nuances.

Day 3, Friday November 4, 2011

On Day 3, we we’re all back in the grand ballroom and during a panel on the best practices for interfacing between third party vendors and client companies, Emma Boyev and David Young of Quintiles, joined Scott Miller of InVentiv and Don Soong of Cegedim to discuss topics that arise as sales teams are outsourced more and more. The panelists stressed that the days of vertically aligned pharmaceutical companies are over and among other topics, offered thoughts on how to organize training in areas like sample management when a third party relationship is in place.

Based on the comments from the attendees, one of the more anticipated presentations was Michael Loucks’ session title “Reflections on My Transition from Government Service to Private Practice.”  Mr. Loucks,  Partner, Skadden Arps and Former First Assistant US Attorney, shared emails and letters he received from those who felt he should be ashamed to now be representing the industry in compliance-related cases.  No matter how one feels about Mr. Loucks, his practice or his opinions, his transition to private practice has certainly generated passion in the industry and with the public.

What I found to be the best presentation of the conference was saved for the last day and it wasn’t even focused on compliance in the pharmaceutical industry. Richard M. Mullane, former astronaut and Colonel, USAF, Retired, took the stage to offer his presentation titled, Creating a Culture of Compliance and Transparency: Lessons from the Challenger Disaster.” Colonel Mullane centered his discussion around what he referred to as the “normalization of deviance” and presented a clear step-by-step case for how the acceptance of short-cutting best practices that had been established early on led to the Challenger disaster. NASA had proof from earlier flights that the o-rings that failed on Challenger had failed in previous flights, but through rationalization brought on by budgetary and political pressure, repeated success of shortcuts in safety became the norm – with the tragic results we all witnessed being the result. Colonel Mullane left the audience with five tips for avoiding this normalization of deviance in dealing with compliance challenges:

• Realize that you are vulnerable
• Plan the work and work the plan (with allowances for situational awareness)
• When the heat is on, reference the plan
• Listen to the people closest to the plan
• Archive and review near misses

I could never fully explain the impact of Colonel Mullane’s comments in this blog, so I suggest if you ever have an opportunity to hear him speak, run, don’t walk. You can also visit his website at www.mikemullane.com to learn more about the man and his message.

Overall, as an exhibitor and an attendee, I was impressed with the Compliance Congress.  The world of pharmaceutical and medical device compliance is changing rapidly and more than ever, well-organized and researched conferences such as this one are a necessary tool for sharing best practices, experiences and knowledge.

There is a crispness in the air, and leaves (and perhaps snow, depending where you are) are falling. It is a wonderful time of year for sure, and this Sunday marks one of the most joyful days of the year – the return to standard time.  We all get an extra hour of sleep! Oh happiness!  We have some business though before Sleepfest 2011 occurs. Keep the fluffy pillow and warm blanket on hold for now, as we present this week’s PC News Week in Review.

We’ll start this week’s review off with a story from the city that never sleeps. New York City agreed to settle charges that it overbilled Medicaid for $70 million.  The DOJ alleged that the city routinely renewed applications for 24 hour continuous care without a review by a local medical director as required by law. City Attorney, Michael Cordoza, said it was in the best fiscal interests of the city to settle the allegations due to the “highly punitive and draconian application of the False Claims Act.” Insert your own Captain Obvious comment here.

Is CMS sleeping on the job when it comes to producing draft guidance for implementing the Sunshine Act? In a letter to Senators Grassley and Kohl, CMS Administrator Don Berwick said the agency was working on the guidance for the implementation of the Sunshine Act, but gave no timetable when the draft guidance will be ready. Mr. Berwick said the delay was due to an executive order which requires federal agencies to reduce regulatory burden (please, try not to laugh), and the agency was still actively working with stakeholders to that end.  Senator Grassley was not pleased saying nothing new had been revealed and that the response was inadequate.

Speaking of executive orders, the President signed an executive order this week requiring the FDA to take certain steps to help deal with drug shortages. In the order, the FDA is to broaden its reporting of potential shortages; speed up approval of applications to change production of drugs headed for shortage; and inform the DOJ of suspected price gouging or collusion.

At the Pharma Congress Mary Riordan said the OIG would not be “falling back” on holding individuals accountable when it comes to healthcare fraud. The same holds true for FCPA investigations. More investigations of individuals for books and records violations of the FCPA are on the horizon.

Also at the Pharma Congress, Assistant Attorney General Tony West discussed healthcare fraud enforcement. In his remarks he cited a number of cases and settlements of healthcare fraud covering several facets of the healthcare industry with the final focus being on cases from the pharmaceutical industry.  As for the future, he indicated there would be a continued focus on individual accountability through use of the Park doctrine. He acknowledged that they know most companies and individuals want “to do the right thing”, and encouraged companies to come forward and self-disclose when problems are discovered.  You can read his full remarks here.

We’ll wrap up this week’s review with the big eye-opener of the week. GSK announced it will pay the U.S. $3 billion to settle criminal and civil investigations which included allegations of illegal marketing and Medicaid fraud. The investigations have been carried out over an eight year period and concern several products.

That does it for the review for this week, but before you run out to buy a Snuggy in preparation for the return to standard time, may we suggest that you stop by the PharmaCertify website first. With healthcare fraud and corruption overseas top priorities of enforcement agencies, we can help you get your teams the information they need with our library of compliance courseware and mobile apps focused specifically on the pharmaceutical and medical device industries.

For all of you in the Northeast, we hope life is back to normal after this past weekend’s snow storm. Now, go get that Snuggy and enjoy your weekend!

The PharmaCertify™ Team

“Did you hear that?” “Sounds like it came from the dark, scary basement that has only one way in or out.” “I think I’ll go down there and check it out – unarmed of course. What could go wrong?”

Ah, the famous last words of more than one victim from horror movies. It is that time of year, when Halloween (insert sequel number here) and Friday the 13^th run practically non-stop on a variety of channels, and we anxiously await the return of the Great Pumpkin. Rest assured, there are no ghosts, goblins or chainsaw wielding psychopaths here at the PC News; just some of this week’s top news items from the world of pharma, bio and med device compliance. So read on good people….if you dare! <click for maniacal laughter>

Let’s start this week’s review with something lurking in the darkness…of physician’s cell phones.

Text messages! Not your average, run of the mill text message, but ones that are sent to other physicians about patients. According to a provider of a secure text messaging platform, around 70% of physicians use text messaging to communicate with other physicians about patients. If PHI is communicated in a text, the physician could be in violation of HIPAA’s security and privacy rules if proper safeguards are not in place.

On to the frightening financial relationship between the industry and physicians. Oklahoma doctors are the latest on the media hot seat based on analysis of Pro Publica’s data. One physician interviewed by Tulsa World said the relationship between the industry and his profession has changed over his 30 years of practice. While he has no problem with information about the financial relationship between doctors and industry being made public, he is concerned the data will be misinterpreted. To that point, the Sunshine Act raises communication concerns for stakeholders affected by the Act.

The former president of a telecom company was handed a blood curdling 15 year prison sentence this week for bribing Haitian government officials. The sentence is the longest one ever handed down in an FCPA case.

A privately held med device company also received a “treat” from the government this week in the form of a nearly $2.4 million settlement over False Claims Act and Anti-kickback violations. The government alleged the company paid physicians for each patient who completed a survey called a User Preference Evaluation. Completion of survey necessitated that the physician use one of the company’s devices, and the majority of the patients involved were Medicare beneficiaries. The government also alleged physicians were provided improper remuneration in the form of travel, expensive meals and entertainment. And if that didn’t give you chills, this just might: healthcare fraud enforcement in 2011 is on track to outpace 2010 by 85%. <click for blood curdling scream >

Next we travel across the dark, murky, foggy waters of the Atlantic to the U.K. where the first individual charged under the U.K. Bribery Act was found guilty this week. The former court clerk could face up to 10 years in prison when he is sentenced in November.

We wrap this up with a word of warning from the FDA: the black licorice which may show up in the trick-or-treat bag can come back to haunt you in a most unpleasant way…especially if you are over 40 (which let’s face it being over 40 is scary enough!). According to the FDA, eating two ounces of black licorice a day for two weeks can lead to irregular heart rhythm. The sweetener used in the licorice, glycyrrhizin, (um…wasn’t that one of Superman’s nemeses?) leads to drops in potassium levels which then leads to arrhythmia, high blood pressure and edema. Medical journals have linked black licorice to health problems in people over 40.

Well that’s the end of this spooktacular edition of the PC News week in review. If you’ll be attending the Pharmaceutical Compliance Congress next week be sure to stop by the PharmaCertify booth (#216) to enter our contest to give this wonderful publication a more fitting name. There just might be something in it for you, plus you get to meet us! We don’t bite…we promise. Seriously, we look forward to meeting many of you next week, and to discussing how we can help you meet your compliance challenges.

This is Halloween time so stay out of the woods, the basement and most importantly, stay away from black licorice as you go about your weekend!

The PharmaCertify™ Team

Big news coming out of 30 Rock this week. Did you hear? The Today show hyped a big announcement last week. Then Monday we found out. It was a brilliant set up. We thought for sure Mr. Lauer would take his leave of the Today show, but no. The big news: Where in the World is Matt Lauer is back for its 10^th installment! Really? That’s it? Well, we here at the PC News have a “big” announcement of our own! We won’t make you wait too long either. However, a small amount of suspense is needed. It wouldn’t be a “big” announcement if there weren’t some suspense, right? As you wait on pins and needles, we give you this week’s PC News Week in Review.

We start the review with a company who is not playing games. Par Pharmaceuticals has filed an action in federal court saying FDA regulations violate the company’s first amendment rights in promoting one of its drugs. The company wishes to promote the drug for on-label uses to physicians who are prescribing the drug for off-label use. Makes sense right? Apparently, because these physicians don’t prescribe the drug on-label, the company can’t promote the drug on-label to them without violating regulations. If that doesn’t have government operation written all over it, what does?

Speaking of the FDA, it was game over for a former chemist with the agency this week, as he pled guilty to insider trading and providing false financial disclosures to the FDA. According to court documents, the chemist made profits or avoided losses totaling $3.8 million using information to which he was privy in his role at the FDA. In the plea agreement, the DOJ agreed to a prison sentence between five and seven years. However, sentencing will not occur until January. The chemist, who has agreed to pay back his illegal gains, could face additional fines.

Public companies, privately held companies; everyone gets to be “it” when it comes to FCPA enforcement. FCPA enforcement actions are up 300% over the last 10 years. While the headline making cases (Seimens for example) tend to be those involving public companies, the majority of individual charges brought since 2008 have been against employees or representatives of privately held companies.

As much fun as the FCPA is, we can’t forget about its cousin across the pond, the U.K. Bribery Act. With the Serious Fraud Office looking for a high profile case, and statements about working closely with the DOJ for potential overlap, it begs the question, is there a big anti-bribery bulls-eye on the pharma industry?

There’s no need to feel that we here in the US are the only ones on the hot seat when it comes to the scrutiny of the financial relationship between healthcare professionals and the industry. A former pharma sales rep in Australia shares all about lunches, speaking fees and marketing tactics with the press. The usual calls for disclosure and changes to codes of conduct follow.

Back here in the good ol’ USA, a professor at the Yale School of Medicine has devised a medical model that promotes the release of all clinical trial data by pharmaceutical companies. He believes this level of transparency in the industry will improve medical care by allowing physicians to completely evaluate if a drug is best for his or her patients. The professor was able to persuade Medtronic to adopt this approach, and he will be meeting with more executives from the industry in December to discuss his model.

Abbott had a couple of big announcements this week as well. Most notably, the company will split into two companies. One company will be a diversified medical products company, and will retain the Abbott name. The other company will be a research-based pharmaceutical company to be named later. In less exciting news, a financial statement showed that Abbott has reserved $1.5 billion to settle a pending off-label case.

A former Guidant sales rep is awarded $2.3 million of the $9.25 million settlement of a False Claims Act suit against the company. The suit charged the company over charged the government for pacemakers and defibrillators.

We’ll wrap this week’s new up with a client alert from Morrison and Foerster, LLP, which recommends that companies consider evaluating their current procedures and processes for physician compensation, in light of risks they may face complying with the Physician Payments Sunshine Act. The data that the law requires to be reported is the type of information typically used in pursuing violations of the Anti-kickback Statute and False Claims Act.

Well that brings us to the end of this week’s review. We hope you had a great weekend pumpkin picking, tailgating or collecting pieces for McDonald’s Monopoly game (anyone out there have Boardwalk?) What? Oh yeah, our “big” announcement…

We here at the PC News have been thinking that the name of our weekly review is, well, dull. Who better than our readers to give the weekly review a great name? So, put your creative caps on and help us give this publication a great name. If you’re attending the upcoming PCF Compliance Congress, stop by our booth with your suggestion. If you won’t be there, stay tuned for more details about how to submit your suggestion. Just think, your name could live for perpetuity on the Internet. And if that isn’t reward enough, well there just might be something else in it for you as well. Keep following us on Twitter (www.twitter.com/pharmacertify) and reading the PC News Week in Review to find out. (We HAVE to leave you with a little suspense!)

The PharmaCertify™ Team

Oh happy day! It’s finally here…iDay! The new iPhone is available! Granted, the iPhone 4S was met with a lukewarm reception by some of the technorati, but the lines formed early this morning anyway. Hey, if the Woz is willing to wait in line for one, it can’t be all bad, right? So while you wait for yours (or are sitting comfortably somewhere laughing at those who have camped out), here’s this week’s PC News Week in Review to keep you occupied.

Facetime with Apple good; face time with judge, not so good. A Washington doctor was sentenced to pay $12,700 in fines and restitution for gifts he accepted from Guidant (a unit of Boston Scientific). The judge said the fine represented every payment the doctor had received from the company. While $12,700 is no small change, this guy certainly wasn’t at the top of Pro Publica’s list of these types of payments. However, the doctor in question worked for the federal government, where accepting payments and gifts over $20 is prohibited.

It was a slow quarter for DDMAC (make that the OPDP) in terms of enforcement. The office issued only four letters; two warning letters and two Notices of Violation. The letters covered both digital and printed media, and dealt with a variety of issues, including unsubstantiated claims and promotional of an investigational drug.

Lawyers are finding a way to “jailbreak” HIPAA for consumers affected by security breaches of their personal health information. HIPAA offers no recourse for consumers to sue covered entities when their information is exposed, but lawyers are finding avenues to sue using state privacy laws.

A couple of stories from the “we’ve got an app for that” file: First, in the wake of the Mediator scandal in France, the French National Assembly has approved a law that would fine advisers to the country’s regulatory agency for failing to reveal conflicts of interest. The law must still be approved by the French senate. If it passes, the law would also require companies to maintain a public register of payments and agreements with those involved with health care. Shades of Sunshine, no?

Also taking a cue from pharma are veterinary medicine schools. Many of the schools are concerned about the influence gifts and meals from feed and pharmaceutical companies may have on decisions made by students and faculty. Some vet schools have created policies that ban or restrict the provision of meals and free products to students and faculty, and require faculty to disclose any relationships they have with these companies. The American Association of Veterinary Medicine Colleges recently adopted a set of ethical guidelines, in the hope that colleges will use the document to develop their own policies.

A new benchmarking survey has revealed that the increase in FCPA enforcement is causing businesses to upgrade their anti-corruption operating systems. The study surveyed over 100 companies globally in areas such as internal audits, procedures in acquisitions, and third-party intermediaries.

If you’ll be doing some Halloween costume shopping after waiting in line for the new iPhone, the FDA has a word of warning for you. Beware of decorative contact lenses. Yes, that set of vampire or werewolf eyes may permanently cause damage if they are not worn, handled or fitted properly. The agency says there is nothing inherently dangerous with the lenses, but they should be purchased from, and fitted by, a qualified healthcare professional and not through a costume store or other outlet. The agency says a qualified professional can also provide proper instruction in care and handling of the lenses.

We’ve reached the end of this week’s review. For those still waiting in line to purchase that phone, we hope you’ve at least moved up a few spaces since you started reading.

One more reminder: The PCF Compliance Congress is scheduled for November 2-4 in Washington DC. Don’t forget to get your early bird discount by registering through PharmaCertify!

Have a good week everyone!

The PharmaCertify™ Team

It’s October and the frost will soon be on the pumpkin, the dreams of a World Series dance in the heads of some lucky baseball fans, and we lament the seemingly earlier and earlier arrival of holiday decorations in our shopping malls and on our city streets.

But before you stress over the prospect of being inundated yet again with the familiar barrage of holiday advertising and mall crowds, let’s take a few minutes to kick back, sip a bit of warm cider and fall into another edition of the PC Week in Review, with the United States Navy Concert Band’s performance of October, by composer Ed Whitacre, for musical accompaniment.

Senators Grassley and Kohl expressed their own bit of October surprise as they joined the chorus of voices questioning whether and when the rules pertaining to the Sunshine Act will be finalized. The October 1 deadline for drafting those regulations came and went without a word from the Center for Medicare and Medicaid Services (CMS). The Senators sent a letter to CMS questioning the agency on the implementation of the provision requiring manufacturers and group purchasing organizations to report all ownership or investment interest held by physicians or members of their family. CMS promptly deflected the blame onto the Office of Management and Budget, saying that agency is responsible for publishing the rule. Oh what a tangled web we weave.

It takes more than ghost and goblins to frighten the University of Rochester Medical Center…it takes the American Medical Student Association (AMSA). With what the organization describes as “the goal of removing drug companies from the practice of medicine,” the AMSA issues grades to American medical schools for their conflict-of-interest policies. The group gave URMC a C on its most recent report card and URMC responded by implementing new rules intended to plug the holes in its policies. The results: gifts from pharma and med device companies are banned and the use of free drug samples is permitted only in limited situations.

According to a new study, 60% of drug companies avoid the gray area of compensating key opinion leaders (KOLs) for the preliminary work associated with consulting services. The study, from Cutting Edge Information, found that the companies are hesitant to compensate for the time spent preparing for a consulting engagement to avoid any potential fines for overpayment. 100% of the companies surveyed did report that they compensate for any travel expenses associated with the consulting services.

If it’s October, it’s the beginning of a new fiscal year for the OIG and it’s time for the release of the OIG FY 2012 Work Plan. The agency posts a new plan every year and in great length (about 165 pages) it explains the activities the government will be monitoring throughout the fiscal calendar.

On the anti-bribery front, FCPA investigations often start where the buck stops. A new study, by Chadbourne and Parke LLP, reveals that top corporate officials are frequently the target of FCPA investigations. In fact, more than one-third of the 61 individuals who were the subject of government investigations under the FCPA in the last six years were top officials in their respective companies. Good anti-bribery training starts with the FCPA and that’s why more clients are utilizing the content in our Essentials of the Foreign Corrupt Practices Act module as a starting point for their comprehensive training.

Speaking of the FCPA, we wonder, if the recipients of a bribe aren’t identified as government officials, should a bribery conviction be dismissed? A Haitian man, who was convicted along with a co-defendant for conspiring to violate and violation of the FCPA and money laundering laws, filed a motion arguing that the government’s evidence was “to show that he knew that Haitian government officials were bribed.” Unfortunately for the defendant, Carlos Rodriguez, and his lawyers, defense lawyers in other cases have not had success in arguing that US has adopted too broad of a definition of “foreign official” to include anyone working for a state-owned enterprise.

Well, that’s it for another edition of the PC News. As we head into the final three months of the year, and you evaluate your 2012 training plan, remember, PharmaCertify offers the custom, and off-the-shelf training modules and mobile apps you need to truly integrate a culture of compliance into your company.

Have a great weekend everyone, and for those of you with baseball teams still in the hunt, good luck. For everyone else waiting for a championship or for finalization of details of the Sunshine Act, hope springs eternal and there’s always next year.

The PharmaCertify™ Team

Shut out and shut down. No, not the Atlanta Braves or Boston Red Sox with their spectacular season ending meltdown, (we can see where one might think that); we’re referring to the NBA’s season opener and who knows how many more regular season games. Contract talks between players and management went no where on Tuesday, so the lockout continues and the season opener appears done for. The good news is both sides are meeting today, so fingers crossed folks. As we wait with baited breath to find out whether we’ll have the joy of seeing Justin Timberlake and Jack Nicholson sitting courtside at Lakers games, check out what news dribbled in here at PC News. Let’s kick off this week’s review. (wait, that was a football reference!) Ally oop! Here we go.

With the full court press on against the financial ties between physicians and the industry, a psychiatrist stands up to point out the educational benefits physicians receive from attending company sponsored education event. The physician, a paid speaker himself, spoke of the positives of learning how colleagues are using certain drugs. He also says talking to other physicians at these programs allows physicians to identify side effects once the medications are used in the “real world.”

HHS’ Agency for Healthcare Research and Quality (AHRQ) is calling a foul on the off-label use of atypical antipsychotic drugs. The AHRQ released an article saying research shows little evidence that the drugs are effective for anything other than the use for which they are approved. Doctors prescribe antipsychotic drugs to treat other conditions such as insomnia and eating disorders. There was some evidence that three drugs in the class were effective in treating dementia, general anxiety disorder and OCD. Beyond the specific drugs cited for the specific conditions, there was no evidence that atypical antipsychotics were effective at treating those same conditions or other conditions for which they might be used off-label.

Federal prosecutors are hoping for a slam dunk this time as the second FCPA sting trial got under way this week. Defendants in the case are accused of bribing foreign officials of Gabon in order to secure lucrative arms contracts. The “foreign officials” were actually FBI agents. Defense lawyers accuse the government of inventing a crime and claim their clients are victims of a shoddy, overzealous investigation. The first trial ended in a mistrial after the jury could not reach a verdict.

Cephalon may find itself in “contract talks” with the government again over off-label promotion allegations. In an SEC filing, the company disclosed it had received a subpoena from the US Attorney’s office for records related to a leukemia drug. No comment from Teva as to what impact, if any, this development will have on its acquisition of Cephalon.

A couple of FCA settlements were announced involving medical device companies. Guidant will lay up (err…lay out) $9.25 million to settle allegations it failed to provide promised warranty services on its defibrillators and pacemakers. Durable medical equipment supplier Hill-Rom will pay $41.8 million to settle allegations it submitted claims for its bed support surfaces for patients who did not qualify for the equipment.

During her comments at the Advanced Medical Technology Conference, HHS Secretary, Kathleen Sebelius, said the government would like to see improvement in the medical device approval process, but more resources would be needed. This means higher user fees. She credited the implementation of a user fee program in the pharmaceutical industry for speeding up the drug approval process. The government and medical device industry have been in talks over a new user fee, but no progress has been made.

The possession arrow is now pointing back to Kentucky in its lawsuit against Purdue Pharma over OxyContin. The state and Pike County, KY filed suit against the company in 2007, alleging the company lied about the addictive nature of the drug, thereby costing the state and county millions in healthcare and law enforcement costs. The case was moved to a federal court in NY in 2008. The Kentucky AG argued that the case should be sent back to Kentucky, and a federal judge in NY agreed.

The shot clock is about to run out on CMS. Regulations for the Sunshine Act are due by October 1! Hope they make it. Vermont marketing disclosure reports are also due October 1. It’s the last state report due for the year. And speaking of state and federal disclosure laws, PharmaCertify can help you train the folks in your organization affected by these laws as well as state laws which prohibit or ban the provision of gifts. Our State and Federal Spend and Disclosure Laws is designed to allow your reps to focus on just the laws that apply to them.

We’re nearing the final buzzer on the work week, and we are happy to let the clock just run on out. Hope you all have a great weekend, and we’ll see you right back here next week for the PC News Week in Review.

Lauren Barnett

Compliance Specialist, PharmaCertify™

Recently, the Financial Times published the results of an analysis of physician spend data conducted in conjunction with a pharmaceutical industry data firm. Publically available data showed that last year firms spent $437 million on meals, speaker fees, travel and the like. A few days later, Pro Publica updated its Docs for Dollars database. Their total for last year was $220 million.

Quite a difference, no?

The Financial Times article went on to say that data thus far this year showed companies had spent $150 million, which put the industry on pace to outspend the previous year. The Pro Publica report in particular was followed by the media hysteria over the amount of money doctors were receiving from physicians. Some local publications reported that spending on doctors in their states was up. One reported doctors were actually paid less.

While it’s entirely possible that companies are spending more, it‘s a bit of a wild west situation in terms of the data being reported at this point. The Financial Times referenced the lack of consistency in the data, with some companies reporting direct spend only and others including spend through institutions. Further, there is the issue of aggregating the data. Over time, the process of collecting and reporting the data is likely to improve. As the number of companies dedicated to helping manufacturers gather the data grows, so too does the accuracy of that data, and the appearance of an increase in spending across the industry.

Perhaps we’ll have a better sense of the state of the financial relationship between physicians and the industry once the Sunshine Act comes on line and all companies are reporting the same information. Until then, I suppose there is some value in evaluating the data now. The recent Pro Publica release did show some interesting changes at the company level, and there is something to be said in knowing your doctor “made the list.” I for one would like to know my doctors at least rate a deli platter for an occasional lunch and learn. If not, I’m asking questions. However, the media hysteria that typically follows this type of report should be dialed down a notch, until there is some consistency in the data.

The PharmaCertify™ Team

Something new and exciting was in the air this week. Or rather on the airwaves. The new TV season kicked off! Finally, after a summer of re-runs and reality shows, the new comedies and dramas (oh, okay, and more reality) are back to entertain. There will be more premiers next week, but in the meantime let us entertain you with this week’s PC News Week in Review.

Are doctors largely avoiding Law and Order when it comes to kickback cases? Avoiding may be a strong word, but despite the lawmakers’ feelings on the topic, doctors are generally not prosecuted when pharma companies are charged with violating the Anti-kickback statue. Why?  One reason cited by an article in the Washington Post was that doctors are not an attractive target for a prosecutor. Doctors face the loss of their license as well as prison time, and thus are willing to spend heavily on their defense. Other reasons include the difficulty in proving a doctor was recommending a product because of a kickback and not because he or she believes in the product, and, prosecutors simply being burned out after dealing with the pharmaceutical company side of the case.

It appears that states Attorneys General are not embracing their authority to bring cases for HIPAA violations with Glee. Since being granted the authority in the HITECH Act, only two AGs have brought cases forward. Rather than use the authority granted them under HIPAA, AGs are choosing to prosecute cases under their states’ own consumer protection and privacy laws.

It’s not Gossip, Girl (a little creative license with the punctuation). The FDA has created some drama (e.g. reorganized) and has turned DDMAC in to the Office of Prescription Drug Promotion. Like any good makeover, the OPDP has more power and authority than it did as DDMAC. The OPDP will have one division dedicated to promotion to physicians and a division dedicated to DTC advertising.

Are you a Modern Family, opting for video chat over that old school technology called the telephone? If so, rest assured that calls you make from your iPad to your doctor are HIPAA compliant. Apple announced that calls made using its FaceTime program are HIPAA compliant with the right network security set up.

Out for Revenge possibly? Two Harvard professors have authored a paper denouncing that changes be made to the FCPA as suggested by the U.S. Chamber of Commerce. The paper’s authors believe changes would undermine the anti-corruption progress that has been made. In particular, the pair call out the compliance program defense and the Chamber’s assertion that a company shouldn’t be held liable for the corrupt activity of a subsidiary.

And if that last story didn’t have the anti-corruption X-Factor you were looking for, check out this video from Main Justice. Main Justice sits down with former head of the SFO’s Business Fraud Group to discuss enforcement of the Bribery Act.

The president of a French pharmaceutical firm may find himself Up All Night for a while as he was placed under investigation this week as part of a probe surrounding an anti-diabetic drug produced by the company. The president and founder of Servier Labortories is under investigation on suspicion of dishonest practices, deception related to the drug’s safety, and falsely obtaining authorization to sell the drug. The drug was largely prescribed as weight loss drug, and its use is being linked to the deaths of 500 people in France.

While we are certainly happy for the new fall shows, we’d be remiss if we didn’t remark on the sad ending of a show that has been around for 41 years. Today marks the last episode of ABC’s daytime soap opera, All My Children. Good-bye Erica Kane and Pine Valley!  It was a great run, and you’ll be missed…evil twins and all.

That brings us to the end of our broadcasting day. Before we sign off, we have a question: what are you doing to renew your compliance training this fall? Do you have a “time slot” to fill with a new topic or maybe there just needs to be a shake up in your current line up. Either way PharmaCertify can help with our selection of off-the-shelf and custom eLearning modules on topics ranging from Aseptic Technique to the PDMA and Sample Management.

We’ll see you right back here next week. Same bat-time, same bat-channel. Have a great weekend!